SmartEye – QMS for Medical Devices
SmartEye Quality Management Software (QMS) is ready for your next audit inspection, before you even know it's happening
Why SmartEye for Design Control and SaMD?
Developing a medical device—especially software-based solutions—requires strict adherence to regulations like FDA 21 CFR Part 820, ISO 13485, and IEC 62304. SmartEye centralizes and automates your design control processes, making it easy to manage:
S-Cube Technologies with its experience in Quality and Regulatory Affairs has proved to know how to keep your company compliant. It has developed an electronic Quality Management System (eQMS) called SmartEye which will guide you to success with its workflows that are already configured to follow all the medical devices standards.
Check the different features that this solution can provide to your company. And don't hesitate to ask for a demo.
Core Processes of a Medical Device Quality Management System (QMS)
SmartEye eQMS is the All in one Solution for your QMS.
These processes form the foundation of a compliant, effective QMS for medical device companies:
Management
These processes ensure strategic alignment, resource allocation, and continuous improvement.
- ✓ Management Responsibility – Setting the Quality Policy and Objectives
- ✓ Quality Planning – Defining how quality will be achieved
- ✓ Management Review – Regular evaluation of QMS performance
- ✓ Resource Management – Ensuring adequate personnel, infrastructure, and environment
Product Realization & Lifecycle Control
Focuses on turning ideas into compliant, safe, and effective medical devices.
- ✓ Design & Development Control – Managing the product design lifecycle
- ✓ Risk Management (ISO 14971) – Identifying and mitigating risks
- ✓ Purchasing & Supplier Management – Qualifying and monitoring suppliers
- ✓ Production & Process Control – Validated manufacturing, traceability, labeling
- ✓ Change Management – Controlled updates to product, process, or documents
Compliance & Documentation
Ensures accurate, controlled documentation and electronic records (if applicable).
- ✓ Document Control – Approval, revision, and version tracking of QMS documents
- ✓ Record Control – Secure handling of quality records (training, audit, complaints)
- ✓ Electronic Records & Signatures (eQMS) – Compliant with FDA 21 CFR Part 11
Monitoring & Improvement
Processes focused on identifying, correcting, and preventing problems.
- ✓ Internal Audits – Periodic review of QMS compliance and effectiveness
- ✓ Nonconformance Management (NCs) – Identifying and handling deviations
- ✓ Corrective & Preventive Action (CAPA) – Root cause analysis and resolution
- ✓ Feedback Analysis – Learning from user and field feedback
- ✓ Post-Market Surveillance (EU MDR) – Real-world performance and vigilance
Support & Compliance Enablement
These supporting processes ensure your QMS is usable, compliant, and scalable.
- ✓ Training & Competence – Ensuring qualified, knowledgeable staff
- ✓ Calibration & Equipment Control – Maintaining measurement accuracy
- ✓ Software Validation (for tools/eQMS) – Ensuring software used in QMS is fit for purpose
- ✓ Labeling & UDI Compliance – Accurate, compliant product identification